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The development of new paradigms for toxicity testing has benefitted the Scottish economy and population in Tayside through two biotechnology companies which, between them, employ up to 40 staff and have had a combined turnover of some £15M over the last five years. The benefits extend to the international pharmaceutical, cosmetic, chemical and consumer product industries, which have gained access to innovative new methods for safety testing at a time of acute need for more predictive methods to evaluate drug safety and better in vitro tests for consumer products. Patients and consumers in Europe and worldwide have benefitted indirectly from improved risk assessment of drugs, consumer products and environmental contaminants.
Drug development is a highly regulated environment. Identifying the need for an independent, academic-led centre of excellence in research and training of pharmacokinetics, we established the Centre for Applied Pharmacokinetic Research (CAPKR) to engage in problems of generic interest to the Pharmaceutical Industry. CAPKR has been highly influential by informing regulatory practice in Europe and the USA, by establishing and optimising industrial practices related to drug development, particularly those related to drug-drug interactions, by reducing the usage of animals in research and by allowing the commercial development and extensive use of simulation software tools for quantitative prediction of pharmacokinetics in order to improve patients' safety.
Research at the University of Sheffield developed pharmacokinetic tools that enable prediction of drug absorption, distribution, metabolism and excretion, and potential drug-drug interactions. In 2001 the University created a spinout company, Simcyp Ltd, to commercialise the technology. The impacts are:
Research by Professor Abdul Basit's group at the UCL School of Pharmacy is leading to improved treatments for ulcerative colitis and other conditions through increased knowledge of the complex physiology of the gastrointestinal tract. Improved understanding of in vivo drug release and uptake has allowed development of three patent-protected technologies for improved drug delivery: PHLORALTM, for release of drugs in the colon, and DuoCoatTM and ProReleaseTM formulations designed to allow intact transit through the stomach followed by immediate release upon gastric emptying. These technologies are the subject of licences and ongoing development programmes, with PHLORALTM currently in phase III clinical trials. The impact is therefore the introduction of enabling technologies that have positively influenced the drug development programmes of pharmaceutical companies.
Innovative formulation science to create and develop the commercially successful PowderHale® technology was undertaken within the Department of Pharmacy & Pharmacology at the University of Bath, and subsequently by Vectura. This has directly provided the basis for novel, potentially life-saving treatments for chronic obstructive pulmonary disease (COPD). Seebri® Breezhaler® and Ultibro® Breezhaler® are once-daily, maintenance bronchodilators for the relief of various symptoms due to airways obstruction caused by COPD. Seebri® Breezhaler® was approved in the EU and Japan at the end of 2012 and has now been launched by Novartis. Ultibro® Breezhaler® a first-in-class combination bronchodilator was approved in Japan and the EU in September 2013. Under the terms of the licence agreement with Novartis concerning these products, Vectura has already received $52.5M with an additional >$100M anticipated upon achievement of regulatory and commercialisation targets. These medicines are major advances to treat and manage a disease that, according to the WHO, affects an estimated 210 million people worldwide and was the third leading cause of death in the developed world in 2012.
i2c Pharmaceutical Services is the trading name for a Cardiff University spin-out company based on Cardiff University research excellence and specialising in pharmaceutical inhaler product research and development. i2c's research in formulation technologies and clinical testing has enabled development of new inhalational medicinal products for the healthcare markets in both developed and emerging countries. Impacts arising from research are at local, national and international levels and evidenced by marketed products, the improved business performance of commercial concerns and the creation of highly skilled jobs.
Edinburgh Napier University is internationally recognised for its research into the mechanisms that drive the adverse health effects of inhaled particles. Pharmaceutical company GlaxoSmithKline (GSK) required early understanding of the likelihood that inhaled drug particulates, used in the treatment of asthma, would evoke an adverse biological response, thus compromising the development of any novel drug. Through collaboration, via a Knowledge Transfer Partnership (KTP), we were able to develop improved in vitro methodologies to study toxicity and, thus, predict pathologies reported in vivo with the aim of reducing both the use of animals and pre-clinical drug attrition.
Research into non-ionic surfactant vesicles (NIV) led to the development of an innovative platform system for delivery of vaccines and drugs, either through oral administration or inhalation. The technology was licensed to a US company, VBI Vaccines in 2008 and led to product development in that company. The adoption of the technology supported the creation of 35 FTE jobs in US/Canada and attracted 50% of the licensor company's Series A VC investment (approximately $18M). It was also adopted by Morvus Technology Ltd. (2010). The University collaborated with Biovaxpahrma Ltd to create a new biotechnology spin out Inhalosome-C, which was awarded a £196k TSB grant in December 2012. The technology is currently being used in commercial R&D in two further companies, Aptuit Ltd and Philips Respiratory Drug Delivery.
Labelled compounds form an essential part of drug discovery and development within the pharmaceutical industry. Novel iridium catalysts, developed by Kerr at WestCHEM since 2008, have introduced a step-change in the ability to label pharmaceutical candidate compounds with radioactive (tritium) or non-radioactive (deuterium) isotopes.
The catalysts are applicable to specific types of compounds that comprise approximately one-third of all drug candidates. Advantages of the catalysts include greater efficacy (less catalyst needed and higher yield of labelled product, giving cost savings), greater speed (efficiency savings), and a significant decrease in radioactive waste compared with previous methods (environmental and safety benefits).
Even since 2008, their adoption within the pharmaceutical industry has been extremely rapid; e.g., the multinational pharmaceutical company AstraZeneca now applies the Kerr methodology to 90% of their relevant candidate compounds. Additional impact has been achieved by Strem Chemicals who have been manufacturing and marketing the catalysts worldwide since October 2012. Even in that very short period, multiple sales have been made on three continents providing economic benefit to the company.
The Abraham solvation parameter approach developed at UCL has become integral to the work carried out by drug discovery teams at [text removed for publication] and other major pharmaceutical companies, as well as research and development groups at international chemical companies including Syngenta and [text removed for publication]. It enables chemists to predict physicochemical and biochemical properties of chemicals, including drugs and agrochemicals, rapidly and efficiently, without the need to conduct time-consuming experiments. The method helps drug discovery teams to identify and optimise the most promising compounds, and often results in fewer compounds being made before a candidate is selected, saving time and resources. The approach has been integrated into software used for drug discovery [text removed for publication].